Prostate Cancer Clinical Trial

Internal Radiation Therapy in Treating Patients With Prostate Cancer

Summary

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells.

PURPOSE: This clinical trial is studying the side effects and how well internal radiation therapy works in treating patients with prostate cancer.

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Full Description

OBJECTIVES:

Primary

To assess the feasibility of high-dose rate (HDR) brachytherapy (without the use of external-beam radiotherapy) as definitive treatment for patients with intermediate-risk prostate cancer.
To assess acceptable toxicity, defined as treatment related toxicity (urinary and rectal), no worse than that seen by patients treated with conventional therapy (grade 3 urinary toxicity < 10% and grade 3 rectal toxicity < 10%).

Secondary

To achieve adequate dosimetric coverage of the prostate comparable to current standards.
To assess the effect of treatment on sexual function.

OUTLINE: Patients undergo 4 high-dose rate brachytherapy treatments over 2 days.

Patients complete bladder, bowel, sexual function, and quality of life questionnaires, including the International Index of Erectile Function (IIEF) questionnaire, the International Prostate Symptom Score Index (IPSS), and the MSKCC Prostate Quality of Life questionnaire at baseline and then at every follow-up visit.

After completion of study treatment, patients are followed every 3 months for 1 year.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

Intermediate-risk adenocarcinoma of the prostate, defined by 1of the following criteria:

PSA 10-20 ng/mL
Gleason score ≥ 7
Stage ≥ T2b AND < T3
Less than 20% risk of seminal vesicle involvement or lymph node involved based upon the Kattan nomogram (pre-treatment risk with IMRT)
Prostate size < 60 cc by MRI or CT imaging
International Prostate Symptom Score Index ≤ 15

Exclusion criteria:

Evidence of definitive extracapsular extension/seminal vesicle invasion or pelvic adenopathy by MRI (endorectal coil) and DRE (digital rectal examination)

Suspected extracapsular disease will not be considered an exclusion criteria
PSA > 20 ng/mL
Presence of distant metastases

PATIENT CHARACTERISTICS:

WBC ≥ 3,500/mm³
Platelet count ≥ 75,000/mm³
Hemoglobin ≥ 10 g/dL
Creatinine ≤ 1.5 mg/dL
Liver function tests ≤ 1.5 times normal
INR ≤ 2.5
Able to complete quality of life questionnaires
Able to give informed consent
No active perineal infections
No history of urethral stricture
No prior history of pelvic malignancy
No prior history of lymphoma disease, ulcerative colitis, or anal fissures
No contraindications to general anesthesia
No pacemaker

PRIOR CONCURRENT THERAPY:

No prior transurethral resection of the prostate
No prior pelvic radiotherapy
No prior treatment for prostate cancer except for hormone therapy

Study is for people with:

Prostate Cancer

Estimated Enrollment:

23

Study ID:

NCT00573833

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

23

Study ID:

NCT00573833

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

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